PATH SOH100098 Hearing Devices: Technical Distortions Risk

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Recalling firmPATHLandsberger Str. 65 · Germering, N/A

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✎ GovInfoNow plain-language explainer

What happened, in plain English

PATH is recalling mobile hearing exam devices with model number SOH100098 because some units may cause more technical distortions than expected during hearing tests. This could lead to inaccurate hearing results if the device is used without proper calibration.

Why it’s dangerous

The device may produce technical distortions that affect hearing test accuracy more than expected. This could lead to incorrect hearing assessments if the device is not properly calibrated or maintained.

Who’s affected

Hearing professionals using PATH's mobile hearing exam devices with model SOH100098 are likely affected. Patients using these devices may be at risk of inaccurate hearing test results.

How to tell if you have this one

Check for model number SOH100098 on the device. Affected units have serial numbers from 201015 to 201029 and UDI-DI code 04260223142437.

Brand
PATH
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Verify the model number is SOH100098 to confirm if your device is affected.

✎ GovInfoNow

Questions people ask

What model numbers are affected?

Model number SOH100098 is affected.

How can I tell if my device is recalled?

Check for model number SOH100098, serial numbers 201015-201029, and UDI-DI code 04260223142437.

What should I do if I have the affected device?

The recall record does not specify a remedy, so contact PATH directly for guidance.

Take action

Contact PATH

We’ve drafted a message you can send PATH to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0401-2024 — PATH PATH

Hello,

I own a PATH that is covered by recall Z-0401-2024 from PATH.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0401-2024 (September 26, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0401-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

PATH recalls SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

Lower-risk recall